IceFORCE® 2.1 CX 90° Cryoablation Needle FPRPR3602Recalls & reported problems

Summary

The FDA's MAUDE database contains 274 adverse event reports that list this exact device (DI 07290104831003), received between May 26, 2017 and Aug 28, 2026 — classified as 4 deaths, 47 injuries, 223 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (65 reports).

2 FDA recall records name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Nov 18, 2020Class IICompleted

   Complaint trend regarding needle shaft gas leaks.

   Z-0657-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Jun 4, 2020Class IITerminated

   The needle surface deteriorated due to unexpected electrolysis during procedure.

   Z-2675-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 274 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50495387 ↗
• MalfunctionAug 24, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50420728 ↗
• MalfunctionAug 19, 2026Difficult to Remove; Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50329746 ↗
• MalfunctionAug 19, 2026Difficult to Remove; Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50329743 ↗
• MalfunctionAug 11, 2026Unsealed Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50201439 ↗
• MalfunctionMay 7, 2026Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS A NEEDLE SHAFT LEAK. AN ICEFORCE 2.1 CX 90 DEGREE NEEDLE WAS SELECTED FOR USE. DURING TESTING, THE PHYSICIAN SAW A BUBBLE COME FROM THE NEEDLE SHAFT DURING ICEBALL FORMATION. ALTHOUGH THE ICEBALL FORMED SUCCESSFULLY, THE PHYSICIAN ELECTED TO NOT USE THE NEEDLE FOR THE PROCEDURE. THE NEEDLE WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25115667 ↗
• MalfunctionApr 16, 2026Insufficient Cooling; Gas/Air Leak

  IT WAS REPORTED THAT A NEEDLE SHAFT LEAK OCCURRED. AN ICEFORCE 2.1 CX 90 DEGREE NEEDLE WAS SELECTED FOR A RENAL CRYOABLATION PROCEDURE. THE PROBE WAS REMOVED FROM PACKAGING WITH NO VISIBLE DEFORMITIES. UPON TESTING, HOWEVER, A BUBBLE WAS FOUND ON THE SHAFT THAT INHIBITED THE FORMATION OF ICE DURING THE FREEZE TESTING PERIOD. THE NEEDLE WAS RETESTED AND SMALL BUBBLES WERE SEEN FORMING AT THE TIP OF THE NEEDLE END. THE NEEDLE WAS UNPLUGGED AND PUT ASIDE. ANOTHER ICEFORCE NEEDLE WAS USED TO COMPLETE THE CASE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24905139 ↗
• MalfunctionMar 24, 2026Gas/Air Leak; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A GAS LEAK OCCURRED ON THE SHAFT OF THE DEVICE. AN ICEFORCE 2.1 CX 90 DEGREE NEEDLE WAS SELECTED FOR A CRYOABLATION PROCEDURE TO TREAT A RENAL CELL CARCINOMA (RCC) INSIDE OF THE PATIENT. DURING THE TESTING PERIOD FOR THE PROCEDURE, BUBBLES WERE NOTED COMING FROM THE METAL SHAFT CLOSE TO THE ELBOW. THERE WERE NO PATIENT COMPLICATIONS, AND THE CASE WAS COMPLETED WITH AN ALTERNATE CRYOABLATION NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24676275 ↗
• MalfunctionOct 30, 2025Nonstandard Device; Defective Device; Nonstandard Device; Defective Device

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN ICEFORCE 2.1 CX 90 DEGREE NEEDLE WAS CHOSEN FOR A CRYOABLATION PROCEDURE TO TREAT A TUMOR IN THE KIDNEY. DURING THE PROCEDURE, THE PHYSICIAN REQUESTED FOR ACTIVE THAW TO ALLOW FOR REPOSITIONING OF THE ICEFORCE 2.1 CX 90 DEGREE NEEDLE TO IMPROVE TREATMENT OF THE TARGET LESION. THE PHYSICIAN NOTED EXCESSIVE ICE FORMATION IN THE KIDNEY DUE TO EXTENDED STICK FREEZE. THE PHYSICIAN REQUESTED THAT BOTH DEVICES ENGAGE ACTIVE THAW. THIS CAUSED THE ICEFORCE 2.1 CX 90 DEGREE NEEDLE AND ICEPEARL 2.1 CX 90 DEGREE NEEDLE DEVICES TO BECOME DISLODGED FROM THE KIDNEY LESION. THE DESIRED POSITIONING OF THE DEVICES IN THE TARGET AREA OF THE KIDNEY WAS LOST DUE TO THE EXCESSIVE ICE FORMATION. THE CASE WAS NOT COMPLETED AND CANCELLED POST-SEDATION BY THE PHYSICIAN DUE TO LOSS OF ACCESS TO THE TARGET AREA. BLEEDING WAS VISUALIZED IN TWO SCANS CONDUCTED AFTER LOSS OF ACCESS. THE BLEEDING AND THE PATIENT CONDITION WAS STABLE AFTER APPROXIMATELY FIFTEEN MINUTES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23430565 ↗
• MalfunctionAug 28, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED A GAS/AIR LEAK OCCURRED ON THE SHAFT OF THE DEVICE. THREE ICEFORCE 2.1 CX 90 DEGREE NEEDLES WERE CHOSEN FOR A CRYOABLATION PROCEDURE TO TREAT A PATIENT. DURING PREPARATION PRIOR TO THE PROCEDURE, AN AUDIBLE NOISE WAS HEARD FROM ONE OF THE ICEFORCE 2.1 CX 90 DEGREE NEEDLES. DURING THE 2-MINUTE TESTING PERIOD, BUBBLES WERE OBSERVED ALONG THE SHAFT OF ONE OF THE ICEFORCE 2.1 CX 90 DEGREE NEEDLES. THE ONE ICEFORCE 2.1 CX 90 DEGREE NEEDLE THAT EXPERIENCED THIS DEVICE ISSUE WAS DISCARDED AND NOT USED INSIDE OF THE PATIENT. AN ALTERNATE DEVICE OF THE SAME MODEL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22917837 ↗
• InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED A SKIN BURN. AN ICEFORCE 2.1 CX 90 DEGREE NEEDLE WAS CHOSEN FOR A CRYOABLATION PROCEDURE TO TREAT A SITE IN THE PATIENT'S KIDNEY. THE PROCEDURE OCCURRED IN A DIFFERENT ROOM THAN THE ONE USED ROUTINELY FOR THIS TYPE OF PROCEDURE. IN ADDITION, THE DEVICE WAS PLACED UNDER ULTRASOUND INSTEAD OF COMPUTED TOMOGRAPHY (CT), SO A DIFFERENT SIZE DRAPE WITH A LARGER FIELD WAS USED THAT EXPOSED MORE OF THE PATIENT'S SKIN. WHEN THE PATIENT WAS MOVED TO TAKE A CT SCAN, IT IS LIKELY THAT THE CRYOABLATION TUBING LAID AGAINST THE PATIENT'S SKIN UNEXPECTEDLY. CONSEQUENTLY, FROSTBITE OCCURRED ON THE PATIENT'S SKIN. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE AND THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: Burn(s)

  MAUDE report 22045502 ↗
• InjuryAug 27, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THE PATIENT EXPERIENCED A SKIN BURN. AN ICEFORCE 2.1 CX 90 DEGREE NEEDLE WAS CHOSEN FOR TREATMENT DURING A LIVER CRYOABLATION PROCEDURE. THE PHYSICIAN NOTICED A BURN ON THE PATIENT'S SKIN DURING THE REMOVAL OF THE DEVICE FROM THE PATIENT. FROST ON THE CABLE OF THE DEVICE WAS OBSERVED. THE PROCEDURE WAS COMPLETED WITHOUT ORIGINAL DEVICE. A WOUND CLINIC HAS BEEN MANAGING THE BURN SITE AND THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: Burn(s)

  MAUDE report 20077488 ↗
• MalfunctionJul 1, 2024Thermal Decomposition of Device; Insufficient Heating; Thermal Decomposition of Device; Insufficient Heating

  IT WAS REPORTED THAT FROST FORMED ON THE NEEDLE SHAFT. AN ICEFORCE 2.1 CX 90 DEGREE NEEDLE WAS SELECTED FOR A RENAL CRYOABLATION PROCEDURE. THREE ADDITIONAL NEEDLES WERE USED FOR THE PROCEDURE, AND ALL TESTED FINE. AFTER EACH NEEDLE WAS PLACED IN THE RENAL TUMOR, THE FREEZE BEGAN. ALL FOUR NEEDLES STARTED TO FREEZE, AND TOWELS WERE PLACED UNDER THE TUBING TO PREVENT FROSTBITE ON THE SKIN. AN ITHAW ERROR APPEARED ON THE CONSOLE FOR THE NEEDLES IN CHANNEL 1A AND 4A. THERE WAS NO TEMPERATURE DISPLAYED, BUT ARGON COULD BE HEARD MOVING THROUGH THE CONSOLE. NINE MINUTES INTO THE FIRST FREEZE, A SCAN WAS PERFORMED, AND THE ICE BALL WAS ACCEPTABLE TO THE PHYSICIAN. THE NEEDLES WERE MOVED DURING THE PASSIVE THAW TO ANOTHER CHANNEL, AND THE SECOND FREEZE WAS STARTED. THE NEEDLES STILL REPORTED ITHAW ERRORS. IT WAS NOTED THAT DURING THE SECOND FREEZE, THE FELLOW HAD NOTICED THAT TWO OF THE NEEDLES HAD STARTED TO FREEZE ALONG THE SHAFT AND WERE FREEZING THE SKIN IN A CIRCULAR PATTERN AT THEIR ENTRY SITE. THE ANESTHESIOLOGIST USED A BIG HOSE THAT BLEW HOT AIR ONTO THE NEEDLES AND ENTRY SITE FOR APPROXIMATELY 10 MINUTES BEFORE REMOVING THE NEEDLES. NO SIGNIFICANT BURN WAS OBSERVED AFTER THE NEED

  Patient problems: Burn(s); Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19645621 ↗
• InjuryJun 18, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THE DEVICE'S VACUUM SLEEVE FAILED AND THE PATIENT EXPERIENCED A SKIN BURN. DURING THE PROCEDURE TO TREAT A RENAL CELL CARCINOMA (RCC), AN ICEFORCE 2.1 CX 90 DEGREE NEEDLE WAS CHOSEN FOR TREATMENT. GENERAL ANESTHESIA WAS ADMINISTERED AT THE START OF THE PROCEDURE. IT WAS REPORTED THE DEVICE'S VACUUM SLEEVE FAILED AND THAT ICE WAS OBSERVED ON THE NEEDLE SHAFT. PATIENT'S SKIN WAS BURNED, THE DEGREE OF BURN IS UNKNOWN. THE PROCEDURE WAS CANCELLED/RESCHEDULE DUE TO THIS EVENT.

  Patient problems: Burn(s)

  MAUDE report 19556918 ↗
• MalfunctionDec 12, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AN AIR/GAS LEAK OCCURRED. A 2.1 ICEFORCE CX 90 DEGREE NEEDLE WAS SELECTED FOR A RENAL CRYOSURGERY. DURING PREPARATION, BUBBLES WERE NOTICED FROM THE DEVICE'S SHAFT AT THE PROXIMAL END WHERE THE METAL MATERIAL CONNECTS TO THE HANDLE. THE NEEDLE WAS FULLY SUBMERGED DURING THE INTEGRITY TESTING. THERE WERE NO PATIENT COMPLICATIONS, AND THE CASE WAS COMPLETED WITH A DIFFERENT DEVICE OF THE SAME MODEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18314504 ↗
• InjuryJun 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT FREEZE BURN OCCURRED. AN ICEFORCE 2.1 CX 90 DEGREE NEEDLE WAS SELECTED FOR A CRYOABLATION PROCEDURE TO TREAT A DESMOID TUMOR. DURING THE FREEZE CYCLE, HOWEVER, AFTER FOUR MINUTES OF MONITORING AND AN ULTRASOUND SCAN, IT WAS NOTICED THAT THE FROSTED PART OF THE TUBING WAS CONTACTING THE PATIENT SKIN. A STERILE TOWEL WAS PLACED BETWEEN THE TUBING AND THE SKIN, AND THE PROCEDURE WAS CONTINUED. SALINE WAS APPLIED TO THE AREA THROUGHOUT THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE ORIGINAL DEVICE. AFTER THE PROCEDURE, STAFF TREATED THE AFFECTED AREA ON THE PATIENT SKIN LIKE A BURN AND DRAPED AND WRAPPED THE ARM. THE PATIENT WAS EXPECTED TO FULLY RECOVER.

  Patient problems: Burn(s)

  MAUDE report 17038797 ↗
• MalfunctionApr 25, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS A GAS LEAK FROM THE NEEDLE SHAFT. AN ICEFORCE 2.1 CX 90 DEGREE NEEDLE WAS SELECTED FOR A CRYOABLATION PROCEDURE TO TREAT RENAL CELL CANCER. DURING THE INTEGRITY TEST, HOWEVER, THE NEEDLE WAS COMPLETELY SUBMERGED IN SALINE, AND A CONTINUOUS STREAK OF BUBBLES WAS SEEN COMING OUT OF THE NEEDLE SHAFT. NO DAMAGE WAS SEEN BY THE OPERATING TEAM. ANOTHER ICEFORCE NEEDLE WAS USED TO COMPLETE THE PROCEDURE, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811729 ↗
• MalfunctionMar 24, 2023Thermal Decomposition of Device; Insufficient Heating; Thermal Decomposition of Device; Insufficient Heating

  IT WAS REPORTED THAT FROST WAS OBSERVED ON THE NEEDLE SHAFT. TWO ICEFORCE 2.1 CX 90 DEGREE NEEDLES WERE SELECTED FOR A CRYOABLATION PROCEDURE. DURING THE PROCEDURE AT THE END OF THE FREEZE CYCLE, AN ITHAW MALFUNCTION ERROR APPEARED ON BOTH NEEDLES. IT WAS ALSO NOTED THAT BOTH OF THE NEEDLES FROZE UP TO THE ENTRY POINT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16610770 ↗
• MalfunctionMar 24, 2023Thermal Decomposition of Device; Insufficient Heating; Thermal Decomposition of Device; Insufficient Heating

  IT WAS REPORTED THAT FROST WAS OBSERVED ON THE NEEDLE SHAFT. TWO ICEFORCE 2.1 CX 90 DEGREE NEEDLES WERE SELECTED FOR A CRYOABLATION PROCEDURE. DURING THE PROCEDURE AT THE END OF THE FREEZE CYCLE, AN ITHAW MALFUNCTION ERROR APPEARED ON BOTH NEEDLES. IT WAS ALSO NOTED THAT BOTH OF THE NEEDLES FROZE UP TO THE ENTRY POINT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16610768 ↗
• MalfunctionFeb 14, 2023Thermal Decomposition of Device; Insufficient Heating; Thermal Decomposition of Device; Insufficient Heating

  IT WAS REPORTED THAT THERE WAS FROST ON THE NEEDLE SHAFTS CAUSING FIRST DEGREE BURNS. FOUR ICEFORCE 2.1 CX 90 DEGREE NEEDLES WERE SELECTED FOR A CRYOABLATION PROCEDURE TO TREAT A RECTAL MASS. DURING THE INITIAL FREEZE, THE SECOND PROBE HAD AN ITHAW MALFUNCTION. THEN, DURING THE SECOND FREEZE, ALL FOUR OF THE ICEFORCE NEEDLES EXPERIENCED INSULATION FAILURES AND FROST APPEARED ON THE SHAFTS. AT THIS POINT, THE THIRD PROBE ALSO HAD AN ITHAW MALFUNCTION. IT WAS ATTEMPTED TO SWITCH THE GAS TANKS. WARM SALINE AND SALINE BAGS WERE APPLIED TO PROTECT THE PATIENT SKIN. FIRST DEGREE BURNS WERE STILL EVIDENT DESPITE THESE EFFORTS. PROBES 2 AND 3 WERE PASSIVELY THAWED WHILE PROBES 1 AND 4 WERE ACTIVELY THAWED, AND ALL FOUR PROBES WERE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, THOUGH IT WAS CUT A LITTLE SHORT. THE PATIENT'S FROST BITE WAS TREATED WITH A TRIPLE ANTIBIOTIC AFTER THE PROCEDURE. THE PATIENT WAS STABLE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 16373527 ↗
• MalfunctionFeb 14, 2023Thermal Decomposition of Device; Insufficient Heating; Thermal Decomposition of Device; Insufficient Heating

  IT WAS REPORTED THAT THERE WAS FROST ON THE NEEDLE SHAFTS CAUSING FIRST DEGREE BURNS. FOUR ICEFORCE 2.1 CX 90 DEGREE NEEDLES WERE SELECTED FOR A CRYOABLATION PROCEDURE TO TREAT A RECTAL MASS. DURING THE INITIAL FREEZE, THE SECOND PROBE HAD AN ITHAW MALFUNCTION. THEN, DURING THE SECOND FREEZE, ALL FOUR OF THE ICEFORCE NEEDLES EXPERIENCED INSULATION FAILURES AND FROST APPEARED ON THE SHAFTS. AT THIS POINT, THE THIRD PROBE ALSO HAD AN ITHAW MALFUNCTION. IT WAS ATTEMPTED TO SWITCH THE GAS TANKS. WARM SALINE AND SALINE BAGS WERE APPLIED TO PROTECT THE PATIENT SKIN. FIRST DEGREE BURNS WERE STILL EVIDENT DESPITE THESE EFFORTS. PROBES 2 AND 3 WERE PASSIVELY THAWED WHILE PROBES 1 AND 4 WERE ACTIVELY THAWED, AND ALL FOUR PROBES WERE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, THOUGH IT WAS CUT A LITTLE SHORT. THE PATIENT FROST BITE WAS TREATED WITH A TRIPLE ANTIBIOTIC AFTER THE PROCEDURE. THE PATIENT WAS STABLE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 16373521 ↗
• MalfunctionFeb 14, 2023Thermal Decomposition of Device; Insufficient Heating; Thermal Decomposition of Device; Insufficient Heating

  IT WAS REPORTED THAT THERE WAS FROST ON THE NEEDLE SHAFTS CAUSING FIRST DEGREE BURNS. FOUR ICEFORCE 2.1 CX 90 DEGREE NEEDLES WERE SELECTED FOR A CRYOABLATION PROCEDURE TO TREAT A RECTAL MASS. DURING THE INITIAL FREEZE, THE SECOND PROBE HAD AN ITHAW MALFUNCTION. THEN, DURING THE SECOND FREEZE, ALL FOUR OF THE ICEFORCE NEEDLES EXPERIENCED INSULATION FAILURES AND FROST APPEARED ON THE SHAFTS. AT THIS POINT, THE THIRD PROBE ALSO HAD AN ITHAW MALFUNCTION. IT WAS ATTEMPTED TO SWITCH THE GAS TANKS. WARM SALINE AND SALINE BAGS WERE APPLIED TO PROTECT THE PATIENT SKIN. FIRST DEGREE BURNS WERE STILL EVIDENT DESPITE THESE EFFORTS. PROBES 2 AND 3 WERE PASSIVELY THAWED WHILE PROBES 1 AND 4 WERE ACTIVELY THAWED, AND ALL FOUR PROBES WERE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, THOUGH IT WAS CUT A LITTLE SHORT. THE PATIENT FROST BITE WAS TREATED WITH A TRIPLE ANTIBIOTIC AFTER THE PROCEDURE. THE PATIENT WAS STABLE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 16373514 ↗
• MalfunctionFeb 14, 2023Thermal Decomposition of Device; Insufficient Heating; Thermal Decomposition of Device; Insufficient Heating

  IT WAS REPORTED THAT THERE WAS FROST ON THE NEEDLE SHAFTS CAUSING FIRST DEGREE BURNS. FOUR ICEFORCE 2.1 CX 90 DEGREE NEEDLES WERE SELECTED FOR A CRYOABLATION PROCEDURE TO TREAT A RECTAL MASS. DURING THE INITIAL FREEZE, THE SECOND PROBE HAD AN ITHAW MALFUNCTION. THEN, DURING THE SECOND FREEZE, ALL FOUR OF THE ICEFORCE NEEDLES EXPERIENCED INSULATION FAILURES AND FROST APPEARED ON THE SHAFTS. AT THIS POINT, THE THIRD PROBE ALSO HAD AN ITHAW MALFUNCTION. IT WAS ATTEMPTED TO SWITCH THE GAS TANKS. WARM SALINE AND SALINE BAGS WERE APPLIED TO PROTECT THE PATIENT SKIN. FIRST DEGREE BURNS WERE STILL EVIDENT DESPITE THESE EFFORTS. PROBES 2 AND 3 WERE PASSIVELY THAWED WHILE PROBES 1 AND 4 WERE ACTIVELY THAWED, AND ALL FOUR PROBES WERE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, THOUGH IT WAS CUT A LITTLE SHORT. THE PATIENT FROST BITE WAS TREATED WITH A TRIPLE ANTIBIOTIC AFTER THE PROCEDURE. THE PATIENT WAS STABLE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 16373509 ↗
• MalfunctionJan 6, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT TWO LEAKS WERE DISCOVERED DURING THE TEST PHASE. THIS ICEFORCE 2.1 CX 90 DEGREE NEEDLE WAS SELECTED FOR A RENAL CRYOABLATION PROCEDURE. DURING THE TESTING PHASE, WHILE OUTSIDE THE PATIENT, THE NEEDLE WAS FULLY SUBMERGED IN SALINE FOR INTEGRITY TESTING AND TWO LEAKS WERE FOUND NEAR THE NEEDLE TIP AND MIDDLE OF THE NEEDLE SHAFT. A NEW NEEDLE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHOUT SEQUELA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16114097 ↗
• InjuryNov 4, 2022Thermal Decomposition of Device; Insufficient Heating; Thermal Decomposition of Device; Insufficient Heating

  IT WAS REPORTED THAT FROST ON THE NEEDLE SHAFTS OCCURRED, RESULTING IN MINOR PATIENT BURNS THAT REQUIRED TREATMENT WITH ANTIBIOTICS. SEVEN ICEFORCE 2.1 CX 90 DEGREE NEEDLES WERE SELECTED FOR A CRYOABLATION PROCEDURE TO TREAT RENAL CELL CANCER IN THE KIDNEY. EACH OF THE PROBES TESTED FINE AND AN INITIAL 10-MINUTE FREEZE WAS COMPLETED. DURING THE SECOND FREEZE, HOWEVER, THE TEMPERATURE BEGAN TO RISE ON EACH OF THE PROBES ALONG WITH THE GAS FIRING INTERMITTENTLY. THE GAS TANKS WERE REPLACED SEVERAL TIMES UNTIL NORMAL FREEZING RESUMED TO COMPLETE THE PROCEDURE. DURING THIS TIME, IT WAS NOTED THAT THREE OF THE SEVEN PROBES HAD FROST ON THE NEEDLE SHAFTS. WARM SALINE BAGS WERE USED TO HEAT THE AREAS OF THE SKIN THAT WERE IN CONTACT WITH THE FROST. THE PROBES WERE USED TO COMPLETE THE PROCEDURE. AN ITHAW MALFUNCTION ALSO OCCURRED WITH ALL OF THE NEEDLES, SO THE SECOND THAW WAS COMPLETED PASSIVELY. THE PATIENT EXPERIENCED MINOR BURNS FROM FROSTBITE, WHICH WERE TREATED WITH ANTIBIOTICS AND HOME CARE FOLLOWING THE PROCEDURE. THE PATIENT WAS EXPECTED TO FULLY RECOVER.

  Patient problems: Burn(s)

  MAUDE report 15730498 ↗